Standard Summary Project Fiche IPA centralised programmes

Standard Summary Project Fiche IPA centralised programmes Project number 30: Chemicals Management 1 BASIC INFORMATION 1.1 CRIS Number: 2008/020-406 1.2 Title: Chemicals Management 1.3 ELARG statistical code: 03.27 1.4 Location: Republic of Serbia Implementing arrangements: 1.5 Contracting Authority: EC Delegation to the Republic of Serbia 1.6 Implementing Agency: EC Delegation to the Republic of Serbia 1.7 Beneficiary (including details of project manager): Ministry of Environmental Protection Republic of Serbia 1 Omladinskih brigada 11070 New Belgrade Tel: +381 11 2158759 Fax: +381 11 2158793 http://www.ekoserb.sr.gov.yu/ Project Manager is Assistent Minister Aleksandar Vesic (aleksandar.vesic@ekoserb.sr.gov.yu) Members of the Steering Committee (SC) will include: 1. Representatives of Ministry of Environmental Protection (MoE), Project Manager (Chair) 2. The EC Delegation Programme Manager for Infrastructure 3. Project Team Leader 4. Other representatives as required The SC will provide advice and guidance on policy matters. It will be responsible for the monitoring and evaluation of project results. The SC will meet at least every 3 months. A PMU will be established the department for chemicals management to assist guidance of project implementation. Financing: 1.8 Overall cost: 1.500.000 EUR 1.9 EU contribution: 1.500.000 EUR 1.10 Final date for contracting: 3 years after the signature of the Financing agreement 1.11 Final date for execution of contracts: 5 years after the signature of the Financing agreement 1.12 Final date for disbursements: 6 years after the signature of the Financing agreement 2 OVERALL OBJECTIVE AND PROJECT PURPOSE 2.1 Overall Objective: To contribute to the minimization of adverse effects of chemicals on human health and environment. 1

2.2 Project purpose: Strengthening of the institutional framework in Serbia (capacities in relevant ministries, research institutes and industry) for effective implementation of legislation on chemicals management by 2012. 2.3 Link with AP/NPAA / EP/ SAA The document "Council Decision on principles, priorities and conditions enclosed in the European Partnership with Serbia and Montenegro from November 2007 ( European Partnership ) defines short-term and medium-term priorities for environmental sector. Among the short-term priorities, under the section European Standards, Environment, is "Strengthen administrative capacity notably of institutions and bodies in charge of planning, permitting, inspecting and monitoring, as well as project management.. Among the medium-term priorities are: Strengthen further the administrative capacity of environmental institutions at national and local level, and Ensure full implementation and enforcement of legislation approximated to the EU legislation. In the Implementation Plan for the European Partnership, Environment, Short-term priorities include: 7.3.1 Continue approximating legislation to EU legislation and standards. 7.3.3 Strengthen administrative capacity notably of institutions and bodies in charge of planning, permitting, inspecting and monitoring, as well as project management. In the medium-term priorities: 7.3.7 Continue implementing and enforcing legislation approximated to EU legislation. 7.3.13 Continue strengthening administrative capacity of environmental institutions and bodies. 2.4 Link with MIPD 1 Under European Standards, Main Priorities and Objectives section 2.2.3.1, the MIPD lists among others: Environment: Support to the approximation and implementation of Environmental legislation and related strategies; support to environmental authorities at all levels in terms of project preparation, management, planning, permitting, inspecting, and monitoring; support to local infrastructure investments including environmental information systems, solid waste, regional land fields, water and sewage. Support for participating in Environmental networks including the European Environmental Agency. Under 2.2.3.2, Expected Results: Environmental laws and by-laws approximated to EU legislation and implemented. Strategies, plans and programmes to ensure implementation of legislation, adopted and implemented. Databases on specific environmental sectors set up. Reinforced administrative capacity of authorities at central, regional and local level in charge of management, implementation and enforcement of environmental legislation and standards. Under 2.2.3.3., Programmes to be Implemented: Support the approximation and implementation of Environmental legislation and related strategies. Assist environmental authorities at all levels in project preparation, management, planning, permitting, inspecting, and monitoring. This project addresses all of these issues by strengthening institutional capacity. 1 Multi-Annual Indicative Planning Document 2

2.5 Link with National Development Plan (where applicable) n/a 2.6 Link with national / sectoral plans Draft National Environmental Strategy policy objectives: The NEP states that the short term policy objectives (2007-2011) in the field of chemicals management are the following; to harmonize national legislation for management of chemicals and risk management with the EU environmental acquis, to revise national regulations on accidents in industry and transport, to ratify important international conventions on chemicals and accidents, to establish and develop an information system for chemicals and risk management, and for ongoing policy objectives (2007-2016) to build professional and institutional capacity for management of chemicals, to establish system for risk management and response to chemical accident. National Profile for Chemicals Management: The National Profile for Chemicals Management provides a comprehensive overview and assessment of the existing national legal, institutional, administrative and technical infrastructure related to the sound management of chemicals. The National Profile addresses the need to strengthen administrative and professional capacities of the staff in governmental bodies. Strengthening of professional capacities is not only based on an increased number of staff, but also on training employees to enable them to implement new regulations, for example, assessment of risks from chemicals to health and the environment, classification and labelling of chemicals, regulatory toxicology, development of socio-economic assessment regarding decision made, etc. Besides employees in the state administration, improvement of professional capacities is also needed in educational and scientific-research institutes regarding chemicals management, building of professional capacities in the chemical industry and industries using chemicals, as well as informing chemical exporters and importers on new administrative procedures in the international chemicals trade. Needs of the Republic of Serbia for International Assistance: In the document Needs of the Republic of Serbia for International Assistance for the period 2007-2009 there is emphasis as priority measure/activities on improvement of the management of chemicals through administrative capacity building for managing chemicals as well as the development of an IT system for managing chemicals. Serbian National Budget for 2008: The Serbian budget for 2008 for the Ministry assures the means for enough employees in the Chemicals Department as well as for the first phase of the chemicals database development. This project will contribute to all these national and sectoral strategies as it will assure Strengthening capacities of institutions, industries and research institutes for implementing chemical-related legislation. 3 DESCRIPTION OF PROJECT 3.1 Background and justification: Sound chemicals management means that chemicals are produced and used in such a way as to minimize the adverse effects to human health and the environment, as emphasized at the Earth Summit on Environment in Rio de Janeiro in 1992 in Chapter 19, Agenda 21. One of the six program areas for sound chemicals management was strengthening of national capacities for management of chemicals. Sound chemicals management represents also one of the objectives of the Implementation Plan of the Earth Summit held in Johannesburg in 2002, where 2020 was indicated as a deadline for fulfilment of the set objective. Aimed at supporting countries to achieve the set objective, a Strategic Approach for International Chemicals Management (SAICM) was adopted in the occasion of the International Conference on Chemicals Management in 2006. SAICM is a global policy framework with a task to coordinate and support a process leading to achievement of the set objective at the Earth Summit in 2002. Within this strategic approach, it is stressed that safe chemicals management relates to sustainable development 3

and it is important to mobilize resources that will help developing countries and countries in transition to achieve the set objective. The European Commission issued a White Paper relevant to the chemicals field in 2001 (document number 2001/C287/01). It sets a number of completely new goals and procedures for raising the level of chemical safety in the EU internal market. The main objective of the new Chemical Strategy is to ensure a high level of protection for human health and the environment, while ensuring the efficient functioning of the internal market and stimulating innovation and competitiveness in the chemical industry. As a result of White Paper on the Strategy for a future Chemicals Policy the Commission adopted new EU regulatory regime for the Registration, Evaluation and Authorisation of Chemicals (REACH). The chemical industry plays an important role in the industrial output and foreign trade of Serbia. This is indicated by data on contribution of the production of plastic and rubber products and petroleum derivates amounting to 21.5 % of GDP compared to the overall industrial output in 2004 as well as contribution of 18 % of the overall value of foreign trade. Today the chemicals industry meets domestic needs in terms of a wide range of products, from basic substances such as petroleum and gas derivates, industrial chemicals (inorganic and organic), intermediate products and finished chemical goods whose number is continuously growing (fertilizers, pesticides, drugs, detergents, cosmetic preparations, paints, adhesives, etc.). The existing legal system for chemicals management is quite different from EU requirements. In Serbia, chemicals are currently regulated by the Law on Manufacture of and Trade in Toxic Substances, published in Official Gazette of FRY No. 15/1995, 28/ 1996, 37/ 2002. Additionally, a number of regulations and decisions exist that complement the Law on Manufacture of and Trade in Toxic Substances (Annex 3). To facilitate the legislative harmonization in this area and to propose proper steps for institution building and capacity development, a CARDS project provided assistance in drafting of Law on chemicals during 2004 and 2005. Two draft laws on chemicals and biocides are finished and they are in the final phase of inter-ministerial coordination. It is planed for these two laws to be adopted after constitution of the Government. Along with preparation of these two laws Ministry for Environmental Protection of Republic of Serbia is preparing by laws that will facilitate implementation of Laws on Chemicals and Biocides. The CARDS team made the following recommendations: the EC should be contacted in order to develop a programme for capacity building. One way to train the civil servants at the national chemicals agency, which will be established after adoption of the Law on Chemicals, in the application of the general law are workshops with civil servants from the Competent Authorities of the EC Member States. The possibility of Serbian civil servants visiting the Competent Authorities of the EC Member States should be evaluated as another option. The Law on Chemicals provides the basis for establishing a chemicals safety system in Serbia. However, responsibilities for chemical policy and management are clearly defined in this Law. In existing legislation, these responsibilities are spread across several governmental institutions with weak coordination, both horizontal and vertical. Inter-sector connection between departments competent for different phases in the life cycle of chemicals is insufficient and should be improved. Although efforts have been made in last two years to improve the chemicals management system in Serbia, there are still several issues to be addressed. Weaknesses in chemicals management in Serbia are the following: Lack of a database on chemical substances and systematic control of chemicals placed on the market Lack of assessment and control of certain chemical effects on human health and environment The system for monitoring of chemicals is not properly developed and needs improvement. 4

Lack of systematic control of the implementation of prescribed risk reduction measures Awareness related to chemical risks is not sufficiently developed, in the wider public on local and central level, but also among all stakeholders. Laboratories are inadequately equipped for quality and quantity analyses of chemicals There is no system to control fulfilment of GLP principles in laboratory (GLP inspectors, GLP monitoring authority). See also Annex 6 of this Project Fish for a SWOT analysis. 3.2 Assessment of project impact, catalytic effect, sustainability and cross border impact (where applicable) Impact The project will contribute to the minimization of adverse effects of chemicals on human health and the environment in Serbia. Catalytic effects and Sustainability The main activities of the project are training using mentorship and gaining experience in a practical learning by doing approach. The project will change training policy, so that training becomes a permanent activity. One of the activities which could derive from the project is to organize training at universities on EU regulatory toxicology as necessary element for chemicals safety in Serbia. 3.3 Results and measurable indicators Result 1 Improved knowledge to enforce chemicals legislation and understanding of integrated chemicals management system within the Ministry of Environmental Protection and selected key stakeholders (such as, Ministry for Agriculture, Forestry and Water Management- Directorate of Plant Protection, Ministry of Health, Ministry of Labour and Social Policy- Directorate for Health and Safety at Work, Chamber of Commerce), laboratories, chemical industry / industries using chemicals, scientific-research institutions. Inter-ministerial and inter-sectoral procedures for sharing of data on chemicals established, awareness raised related to various issues of chemicals safety, website developed. An action plan developed that sets up future activities in relation to the integrated chemical management system in Serbia. Measurable indicators are the following: Skills and knowledge of ministerial staff and personnel of all stakeholders Degree of development and use of the new training strategy/policy Degree of development and use of new technical guidelines Stage of development/adoption of manual and procedures for data sharing Intensity of operational sharing of data on chemicals between relevant sectors/ministries Number and quality of stakeholder contributions Degree of finalisation of the plan. 5

Result 2 Laboratories for crucial operation of the system for chemicals management and implementation of regulations have improved their performance. Measurable indicators are the following: Number and quality of laboratory analyses and reports 3.4 Activities: Activities related to result 1 1.1 Establish new training strategy/policy using the mentorship approach and gaining experience by practical learning by doing process through inter-sectoral groups 1.2 Extensive and comprehensive training of selected key representatives from the public administration, institutions, industry, scientific-research institutions, 1.3 Prepare and adopt technical guidelines for stakeholders 1.4 Preparation of manual and procedures for data sharing development 1.5 Prepare and carry out a media campaign for raising public awareness related to various issues of chemicals safety 1.6 Develop the website 1.7 Prepare evaluation questionnaires and seminars/meetings with stakeholders 1.8 Develop an action plan that sets up future activities in relation to integrated chemical management system in Serbia These activities will be organised through a twinning project. The project activities will be measured by number of organized trainings, evaluation of participants assessment of completed training and the number of prepared guidelines. Within the project it is planed to organize minimum 14 trainings with approximately 370 participants. Also it is planned to prepare more than 5 technical guidelines which could be used as training tools and in the everyday work of the trained staff. Training will be evaluated by evaluation questionnaires. Usefulness of guidelines will be evaluated by interviews of their users. Training and technical guidelines will include: 1. Registration, risk assessment of substances (preparation of chemicals safety assessment and chemicals safety report as well as usage of IUCLID 5 the basic tool for data collection) 3 trainings for 30 participants for representatives from government authorities, industry and scientific sector 2. Risk management decision making preparation, socio-economic analysis according to REACH - 2 trainings for 20 participants for representatives from government authorities, industry and scientific sector 3. Authorization of substances - 1 training for 15 participants for representatives from government authorities and industry 3. Advance education in classification, packaging and labelling according to GHS preparation of guidelines and 2 training for 25 participants for representatives from government authorities, industry and scientific sector 4. Safety and health at work with chemicals- preparation of guideline and 1 training for 30 participants for representatives from government authorities and industry 6

5. Chemicals waste preparation of guidelines and 1 training for 35 participants for representatives from government authorities, industry and scientific sector 6. Regulatory toxicology/eco-toxicology - preparation of curricula for university on regulatory toxicology/eco-toxicology and 1 training 20 participants for authority and industry representatives 7. Horizontal compatibility of chemicals life-cycle legislation, enforcement/control etc. preparation of guidelines and 3 trainings 30 participants for inspections 8. Prepare and carry out a media campaign for raising public awareness related to various issues of chemicals safety (this can be measured by the number of publicity events executed and their success). 9. Develop the website which will enable wider public access to information related to chemical safety, and also address issues of interest for specific target groups. Activities under 1.7 and 1.8 are important in terms of preparation of appropriate future activities and projects. The output will be a document that will reflect the future plan and stakeholders involvement in this plan. This plan will be developed by questionnaires as well as 2 workshops where stakeholders will determine priorities Activities related to result 2 2.1 Procurement of laboratory equipment Laboratory equipment is required for crucial operation of the system for chemicals management and implementation of regulations to improve laboratory capacities. Within the KemI/SIDA project it is planned to assess the necessary laboratory equipment which should be purchased for chemicals control. The main indicator is measured from reports of purchased laboratory equipment, trained staff and performed laboratory studies. Contracting Arrangement: The project will be implemented through one twinning contract and one supply contract for laboratory equipment. 3.5 Conditionality and sequencing Conditionality A sufficient number of employees in the Ministry and other related institutions in charge of chemical management are already in place for the implementation of this project. The Ministry is responsible for chemical management personnel throughout the country having the necessary resources to carry out their duties based on the outputs of this project. Also it is necessary to prepare within the KemI/SIDA project an analysis of necessary laboratory equipment which should be purchased for chemicals control. A detailed analysis of existing laboratory equipment is prepared in the National Profile for chemicals management. Sequencing There are linkages between supply and twinning components of the project but since the analysis of laboratory equipment to be purchased will be prepared within the KemI/SIDA project, there are no essential sequencing needed of these two components. Training should be organized during the whole duration of the project. 7

Development of the Action Plan as activity 5 should be organized in last phase of the project but the material for the action plan will be collected during the whole duration of the project. Phases for the establishment of the inter-sectoral network for implementation of chemicals legislation are described in part 3.4. 3.6 Linked activities The EU and bilateral donors have financed a number of activities and projects in building administrative capacity in the field of environmental protection. Technical assistance for drafting the law on chemicals was obtained through the regional CARDS project Assistance in Environmental Law Drafting in South Eastern Europe implemented by the Regional Environmental Centre for Central and Eastern Europe whose beneficiaries are countries of SEE. Apart from this project, whose goal was assistance in drafting legislation, the Ministry of Environmental Protection is implementing the following projects: 1. Enabling Activities for the Development of a National Plan for Implementation of the Stockholm Convention on Persistent Organic Pollutants (POPs) funded by the Global Environment Facility. The purpose is to build capacity in Serbia to fulfil all obligations that result from this convention, in particular to develop a National Implementation Plan (NIP). The implementation agency of this project is United Nations Environment Program (UNEP). This Project should be finished at the end of 2008. ( http://www.ekoserb.sr.gov.yu/projekti/pops/index.php ). As one of the activities within the POPs Project, the Ministry has prepared a document National Profile for Chemicals Management. The National profile represents an overall estimation of the current state of chemicals management in Serbia through the so-called overall chemical "life-cycle", from production to disposal and provides an analysis of legislative, institutional, administrative, professional and technical aspects of chemicals management in Serbia. The National Profile addresses the need to strengthen administrative and professional capacities of the staff in governmental bodies. 2. In order to ensure sound chemicals management in Serbia, The Ministry of Environmental Protection has started work on the project Updating a National Chemicals Management Profile, Development of a National SAICM Capacity Assessment, and Holding of a National SAICM Priority Setting Workshop in Serbia. This Project started in August 2007 and it should be finished in February 2009. The financial support for this Project is provided by the SAICM Quick Start Programme Trust Fund. (http://www.ekoserb.sr.gov.yu/projekti/saicm/index.php) This Project will help the Ministry to recognize the Johannesburg Plan of Implementation that sets the goal of ensuring sound management of chemicals world-wide by 2020, and a Strategic Approach to International Chemicals Management (SAICM), that is concerned with enhancing co-ordination and coherence of chemicals management both at the international and national levels. This Project will also help the Ministry to recognize the importance of SAICM s Overarching Policy Strategy which states that implementation of the Strategic Approach could begin with an enabling phase taking into consideration national profiles, action plans, stakeholder initiatives and gaps, priorities, needs and circumstances. It will provide assessment of capacity for a more realistic action plan. This SAICM project will contribute to Activity 5 of this project Development of Action Plan that set up the activities for future improvement of the chemicals management system in Serbia. 3. In order to approximate domestic legislation and institutions to the REACH-system, the Ministry of Environmental Protection will start work on the project Chemicals risk management in Serbia. This Project will last until 2010. The financial support for this Project is provided by Swedish International Development Cooperation Agency (Sida) and Swedish Chemicals Agency (KemI). The main goals of this Project are that the systems for classification, labelling and safety data sheets are introduced to the industry 8

at a national level and that relevant stakeholders are engaged in the introduction of these systems as well as establishment of the core administration for chemicals risk management. This project will also contribute to obtaining basic knowledge as a necessary element for obtaining advance knowledge on REACH, risk assessment an EU committology within this Project. Within the KemI/SIDA project it is also planned to assess the necessary laboratory equipment. 3.7 Lessons learned Within the CARDS project, a study visit to the Slovenian Chemicals Bureau and European Chemical Bureau (ECB) was organized, where the Ministry s drafting team was in a position to see how different parts of legislation were developed, implemented and enforced. The key lesson that emerged from this visit was the need to strengthen enforcement and control mechanisms in Serbia, in order to achieve final practical compliance with the EU chemical safety system. The visit also highlighted the fact that chemical regulations are very complex and all new member states, including Slovenia, in the pre-accession period required several institutional building projects. Strengthening capacities of institutions, industries and research institutes for implementing chemical related legislation is the main tool to achieve sound chemical management in Serbia. 9

4 INDICATIVE BUDGET (AMOUNTS IN ) SOURCES OF FUNDING TOTAL EXP.RE IPA COMMUNITY CONTRIBUTION NATIONAL CONTRIBUTION PRIVATE CONTRIBUTION ACTIVITIES IB (1) INV (1) EUR (a)=(b)+(c)+(d) EUR (b) %(2) Total EUR (c)=(x)+(y)+(z) % (2) Central EUR (x) Regional/ Local EUR (y) IFIs EUR (z) EUR (d) % (2) Activity 1 contract 1.1 X 1,000,000 1,000,000 100 Activity 2 contract 2.1 X 500,000 500,000 100 TOTAL IB 1,000,000 1,000,000 100 TOTAL INV 500,000 500,000 100 TOTAL PROJECT 1,500,000 1,500,000 100 NOTE: DO NOT MIX IB AND INV IN THE SAME ACTIVITY ROW. USE SEPARATE ROW Amounts net of VAT (1) In the Activity row use "X" to identify whether IB or INV (2) Expressed in % of the Total Expenditure (column (a)) 10

5 INDICATIVE IMPLEMENTATION SCHEDULE Contracts Start of Tendering Signature of contract Contract 1.1 T + 1 Q T + 4Q T + 12 Q Contract 2. 1 T + 3Q T + 7Q T + 11 Q Project Completion 6 CROSS CUTTING ISSUES 6.1 Equal Opportunity The project will be committed to equal opportunities in employment. 6.2 Environment Improvement of environmental protection is the concrete subject of this project. 6.3 Minorities As minorities and vulnerable groups are usually the most affected by environmental degradation, improvements resulting from this project will also be or particular benefit to them. 11

ANNEX I: LOGICAL FRAMEWORK MATRIX LOGFRAME PLANNING MATRIX FOR Project Fiche Chemicals Management Contracting period expires 3 years after the signature of the Financing Agreement Total budget: 1, 5 mil. EUR Disbursement period expires 6 years after the signature of the Financing Agreement IPA budget: 1, 5 mil. EUR Overall objective Objectively verifiable indicators Sources of Verification To Contribute to the minimization of adverse effects of chemicals on human health and environment. Reduced effects of chemicals on human health and environment Report on state of the environment in Serbia, made by Serbian Environmental Protection Agency Project purpose Objectively verifiable indicators Sources of Verification Assumptions Strengthening of the institutional framework in Serbia (capacities in relevant ministries, research institutes and industry) for effective implementation of legislation on chemicals management by 2012. Improved enforcement of chemicals legislation by the end of 2011 Improvements in the administration for chemicals risk management Progress in developing technical guidelines for administration and industry and putting them into force Serbia s Progress Report made by EU Commission The published comprehensive list of wider framework inter-sectoral chemical safety legislation Prepared drafts of new/reviewed Serbia regulations and/or final versions published in the Official Gazette Report of the MSs short term expert(s) with results of horizontal cross-check the wider legislation provided to all the relevant sectors Other ministerial reports Government officials, industry representatives and other relevant stakeholders are interested in improving their knowledge 12

Results Objectively verifiable indicators Sources of Verification Assumptions 1. Improved knowledge to enforce chemicals legislation and understanding of integrated chemicals management system within the Ministry of Environmental Protection and selected key stakeholders, laboratories, chemical industry / industries using chemicals, scientific-research institutions, Interministerial and inter-sectoral procedures for sharing of data on chemicals established, awareness raised related to various issues of chemicals safety, website developed.. An action plan developed that sets up future activities in relation to the integrated chemical management system in Serbia 2. Laboratories for crucial operation of the system for chemicals management and implementation of regulations have improved their performance. Skills and knowledge of ministerial staff and personnel of all stakeholders Degree of development and use of the new training strategy/policy Degree of development and use of new technical guidelines Stage of development/adoption of manual and procedures for data sharing Intensity of operational sharing of data on chemicals between relevant sectors/ministries Awareness of citizens and professional stakeholders Participation in public hearings No. of website visitors No. and quality of stakeholder contributions to the development of regulation in specific subjects Number and quality of stakeholder contributions Degree of finalisation of the plan Number and quality of laboratory analyses and reports Stage of installation / operationality of laboratory equipment Questionnaire surveys of trained personnel after a period of working Certificates and evaluation forms for participants involved in workshops, educational events and training courses Official reports from meetings Ministerial reports Frequency reports on chemicals information exchange within network Data base manual Survey of public awareness Survey within professional circles Number of website visitors Text of Action Plan Project reports Ministerial reports Laboratory reports Documentation on purchase and installation of laboratory equipment Trained staff in administration and other authorities responsible for chemicals management continue to implement acquired knowledge Suitable staff are available to take part in training workshops, educational events and training courses EU institutions and international organizations are in position to invite Serbian participants Government authorities are interested in inter-ministerial and intersectoral electronic networks establishment and information-sharing Stakeholders and key partners are willing to participate in preparation of the Action Plan 13

Activities Means Costs Assumptions Activities related to result 1 1.1 Establish new training strategy/policy using the mentorship approach and gaining experience by practical learning by doing process through inter-sectoral groups 1.2 Extensive and comprehensive training of selected key representatives from the public administration, institutions, industry, scientific-research institutions, 1.3 Prepare and adopt technical guidelines for stakeholders 1.4 Prepare manual and procedures for data sharing development 1.5 Prepare and carry out a media campaign for raising public awareness related to various issues of chemicals safety 1.6 Develop the website. 1.7 Prepare evaluation questionnaires and seminars/meetings with stakeholders Twinning Supply 1.0 million Euro Trained staff in administration and other authorities responsible for chemicals management continue to implement acquired knowledge Suitable staffs are available to take part in training workshops, educational events and training courses EU institutions and international organizations are in position to invite Serbian participant Government authorities are interested in interministerial and inter- sectoral electronic procedures establishment 1.8 Develop an action plan that sets up future activities in relation to integrated chemical management system in Serbia Activities related to result 2 2.1 Procurement of laboratory equipment 0.5 million Euro Stakeholders and key partners are willing to participate in preparation of the Action Plan Total 1.5 million Euro 14

ANNEX II: (IPA contribution only) AMOUNTS (IN MILLION ) CONTRACTED AND DISBURSED BY QUARTER FOR THE PROJECT Contracted QR1 QR2 QR3 QR4 QR1 QR2 QR3 QR4 QR1 QR2 QR3 QR4 Total Contract 1.1 1.000.000 1.000.000 Contract 2.1 500.000 500.000 Cumulated 1.000.000 1.500.000 1.500.000 Disbursed Contract 1.1 100.000 225.000 225.000 225.000 225.000 1.000.000 Contract 2.1 225.000 225.000 50.000 500.000 Cumulated 100.000 325.000 550.000 775.000 1.000.000 1.225.000 1.275.000 1.500.000 1.500.000 15

ANNEX III: INSTITUTIONAL FRAMEWORK The Ministry of Environmental Protection is responsible for chemicals management and has in it s organization structure a Chemicals Department responsible for: Enforcement of the main Law on Production and Trade of Poisons («Official Gazette of FRY», 15/95) regulating chemicals as products Preparing new regulations harmonized with EU legislation Preparing strategic documents on chemicals management Preparing for ratification and implementing of ratified international agreements such as the Stockholm convention, Rotterdam convention, and the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction Projects for the training of governmental bodies, industry and scientific-research sectors for modern chemicals management Other activities necessary for safe chemicals management (identification of necessary laboratory equipment for legislation implementation control, information system development, etc). Within the new organizational structure the Chemical Department consists of a Unit for Register and Administrative Procedures and a Unit for the Development of the Chemical Management System. In 2008 it is expected to have 13 permanent personnel employed in the Department. 16

ANNEX IV: REFERENCE TO LAWS, REGULATIONS AND STRATEGIC DOCUMENTS: The Law on Ministries forms ministries and special organizations and defines their responsibilities («Official Gazette of RS», No. 43/07). The Law on Ministries prescribes that the Ministry of Environmental Protection is responsible for chemicals management. Certain issues concerning chemicals management are, however, in the jurisdiction of other ministries: The Ministry of Agriculture, Forestry and Water Management - Directorate for Plant Protection is responsible for plant protecting and nutrition agents (pesticides and fertilizers) The Ministry of Health is responsible for enforcement of the Law on Health Safety of Food and Consumption Goods (cleaning agents and cosmetic products) and Law on substances used in prohibited production of narcotic drugs and psychotropic substances The Ministry of the Interior is in charge of enforcement of the Law on explosive substances, flammable liquids and gasses and the Law on trade in explosive substances The Ministry of Labour and Social Policy - Directorate for Occupational Safety and Medicine is responsible for enforcement of the Law on occupational safety and medicine, and therefore of implementation of measures concerning chemicals management at work. There are three ministries responsible for enforcement of the Law on Transport of Dangerous Goods: Ministry of Infrastructure, Ministry of Interior and Ministry of Environmental Protection. In accordance with the Law on Ministries, the Environmental Protection Agency within the Ministry of Environmental Protection is responsible for certain aspects of chemicals management, so recently it has started a process of development of the Pollutant Release and Transfer Register aimed at implementation of the Protocol on Pollutant Release and Transfer Register of the Aarhus Convention. Additionally, a number of regulations and decisions exist that complement the Law on Manufacture of and Trade in Toxic Substances (Annex 3_). - Regulation on Criteria for Classifying Poisons into Groups and Methods for Determining the Degree of Toxicity of Particular Poisons, published in Official Gazette of FRY No. 79/ 1991; - Regulation on Methods of Destroying Unused Poisons and Packaging for Poisons, and on Withdrawal of Poisons from Trade; - Regulations on the Conditions to be Fulfilled by Organizations that Issue Toxicological Certificates (Assessments) of Poisons and Organizations that Evaluate Poison Efficacy; - Decision on the Labelling of Marketed Poisons, published in Official Gazette of FRY No. 38/ 1997; - Decision on Conditions which must be fulfilled by Legal Persons and Entrepreneurs which Produce, Trade and Control Poisons, published in Official Gazette of FRY No. 30/ 1996; - Decision on Conditions to be Fulfilled by Legal Entities that Perform the Tasks of Poison Control Centres; - Criteria for Studies and Evaluation of Efficacy of Poisons to be used for Public Hygiene. 17

ANNEX V: DETAILS PER EU-FUNDED CONTRACT (*) WHERE APPLICABLE: Twinning covenant: Establish new training strategy/policy using the mentorship approach and gaining experience by practical learning by doing process through inter-sectoral groups Extensive and comprehensive training of selected key representatives from the public administration, institutions, industry, scientific-research institutions, Facilitate drafting of technical guidelines for stakeholders Prepare manual and procedures for data sharing development Prepare tender documentation for the procurement of appropriate hardware for establishing an inter-sectoral network for implementation of chemicals legislation. Prepare tender documentation for the procurement of laboratory equipment Prepare tender documentation for the media campaign for raising public awareness and for developing the website. Prepare evaluation questionnaires and seminars/meetings with stakeholders Facilitate development of an action plan that sets up future stakeholder activities in relation to integrated chemical management. Conduct an information campaign targeted at the general public and defined stakeholder groups, as designed by the Ministry with the assistance of the twinning partner.. Design an appropriate website as specified by the Ministry with the assistance of the twinning partner. Supply contract: Laboratory equipment 18

ANNEX VI: SWOT ANALYSIS STRENGTHS The Law on environmental protection harmonized with EU legislation The Law on chemicals and the Law on biocides harmonized with European legislation National profile for chemicals management is finished and National implementation plan for POPs chemicals management is in process of preparation Priority setting project for implementation of action plan for Strategic Approach to International Chemicals Management approved by SAICM fund Chemicals risk management in Serbia Chemicals department budget is increased and extra budget is also approved for employment of new employees In the Chemical Department it is clear what should be future picture for improvement of chemical safety in Serbia In the recent future it is planed to employ several more motivated young employees Draft Law for the ratification of Rotterdam convention is prepared WEAKNESES Current chemical management legislations are not in line with EU legislation Lack of data bases and systematic control of chemicals witch are placed on the market Monitoring system for dangerous chemicals, POP s chemicals is not sufficiently developed Lack of systematic control of certain chemicals effects to human health and environment as well as lack of systematic control of the fulfilment of prescribed risk reduction measures Insufficient inter-sector connection between departments competent for different phases in life cycle of chemicals Lack of financial resources and professional capacitates for enforcement of new legislation Lack of technical guidelines for legislation enforcement OPPORTUNITIES Chemicals management is one of priorities of Serbian Government and European partnership Using of international funds and foreign investments is possible In Government strategies one of priorities is to ratify Stockholm and Rotterdam convention Serbia aspires to accession to the EU Government bodies are aware of necessity of chemical management system improvement Existing pool of experts in educational and research institutions and their willingness to acquire specific knowledge THREATS Insufficient administrative and professional capacitates in government bodies responsible for chemical management Financing system for solving problems caused by chemicals is inefficient The public awareness related to chemicals risk is not sufficiently developed Laboratories are inadequately equipped for quality and quantity analyses of chemicals and there is no system to control fulfilment of GLP principles in laboratory (GLP inspectors, GLP Monitoring Authority) Lack of trained staff in regulatory toxicology and risk assessment in industry and educational and research institutions 19